fda impotent, needs viagra

i was going to ramble on about the state lawmaker from west virginia who has proposed a bill to ban barbie dolls on the premise that "the Barbie doll, I think, gives emphasis on if you're beautiful, you don't have to be smart", but decided that the topic was already absurd enough and didn't need any ridicule from me. instead, i will ramble about the recent supreme court ruling regarding regulatory pre-emption.

the facts of the case (from what i understand) are this:

• wyeth, a pharmaceutical company, created a drug (called phenergan) for treating migranes. the drug and drug warning label were approved by the FDA.
• a certain method for administering the drug carries a risk of gangreen, and there was no warning about this on the FDA approved warning label.
• a woman had to have her arm amputed as a result of being treated via the method described above and sued wyeth.
• wyeth claimed that since the fda approved the warning label, they could not be held responsbile and the the fda's approval essentially immunized wyeth from lawsuits.
• the supreme court ruled that "that Phenergan's label did not contain an adequate warning about the IV-push method of administration" and that wyeth's defense did not hold. the woman was awarded $6.7M.

now, while i don't disagree that if wyeth knew about this risk, they undoubtedly, should have included this on the warning label, it does make me wonder what the hell is the point of the FDA approval process?

the whole purpose of regulatory bodies like the FDA is to assure some degree of quality & safety to the general public. these agencies exist because it is generally believed that it's not possible for an average consumer understand all the risks they are faced with (and is a topic worthy of it's own rant), be it with respect to automotive safety, the grade of your beef, prescription drugs, or toy dolls that send the wrong message. there are probably hundreds of the agencies; FDA, USDA, NHTSA, SEC, FTC, CPSC and on and on...

the supreme court effectively ruled that FDA approved warning labels do not sufficiently divulge the risks inherent with the use of some drugs. this inevitably leads to the question, if the FDA approves insufficient warnings, how can i trust them? if i can't trust them, then why do they exist? the supreme court essentially rendered the FDA impotent, and have possibly set the same precedent for all regulatory agencies.

without getting into an argument about whether the fda should or should not exist, they should be held responsible in cases like this. if the FDA knew about this risk and approved the label without a proper warning and had the legal authority to force wyeth to include it, the FDA is equally responsible.